Contribution to autorship
All authors contributed substantially to the work, provided important
intellectual content, had full access to data and had the final
responsibility for the decision to submit for publication. ASB
(coordinating investigator) had full access to all the data in the study
and takes responsibility for the integrity of the data and the accuracy
of the data analysis. All members
of the scientific committee (ASB, FJM, AM, CH and JMG) participated
actively in the trial design, the monitoring of inclusions, data
validation, data analysis and interpretation; they also demonstrated
strong commitment to informing and motivating the study investigators
throughout the trial. All investigators (FB,JC,AL,TR,FB,FV,AL and FIDEL
Working group investigators) contributed actively to the inclusions,
their monitoring, data validation and analysis.